The Azurion series (within the limits of the Operation Room table) are intended for use to perform · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. · Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: - · The Azurion series can be used in a hybrid Operation Room · The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

Device Description

The Azurion R2.1 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion R2.1 interventional fluoroscopic X-ray system include: Real-time image visualization of patient anatomy during procedures Imaging techniques and tools to assist interventional procedures Post processing functions after interventional procedures Storage of reference/control images for patient records Compatibility to images of other modalities via DICOM Built in radiation safety controls This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Azurion R2.1 is available in comparable models and configurations as the currently marketed and predicate device Azurion R1.2. Configurations are composed of detector type (monoplane and biplane), floor or ceiling mounted geometry, standard or OR table type and available image processing. The FlexArm option is available for the 7M20 configuration in Azurion R2.1 The monoplane (single C-arm) and biplane (dual arm) X-ray system configurations are differentiated by the following features: 12 inch Flat Detector (FD12) 15 inch Flat Detector (FD15) 20 inch Flat Detector (FD20) Additionally, identical to the predicate device, Azurion R2.1 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

AI/ML Overview

The provided text describes the Azurion R2.1, an image-intensified fluoroscopic x-ray system, and states that it did not require clinical study data to demonstrate substantial equivalence to its predicate device, Azurion R1.2. Therefore, this document does not contain the detailed information typically found in a study proving the device meets acceptance criteria through clinical performance data.

Instead, the submission relies on demonstrating substantial equivalence based on:

Indications for Use
Technological Characteristics
Non-clinical performance testing
Safety and Effectiveness

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical verification and validation activities summarized.

Here's an analysis of the provided text in relation to your request, noting where information is explicitly stated and where it is absent because no clinical study was conducted:

1. A table of acceptance criteria and the reported device performance

The document mentions that "Results demonstrated that all executed verification tests were passed" and "Results demonstrated that all executed validation protocols were passed" in the non-clinical performance and validation sections. However, it does not provide a specific table of acceptance criteria with corresponding device performance metrics. The general acceptance criteria are compliance with specified standards, user needs, and safety requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 62304 (Medical device software)	Passed software verification testing; results demonstrated all executed verification tests were passed.
Compliance with ISO 14971 (Risk management)	Safety risk control measures from the Detailed Risk Management Matrix have been implemented.
Compliance with IEC 60601-2-28 (X-ray tube assemblies)	Complies with the standard.
Compliance with IEC 60601-2-43 (X-Ray equipment for interventional procedures)	Complies with the standard.
Compliance with FDA guidance documents for software and 510(k) programs	Complies with the guidance documents.
Conformance to intended use, claims, user and service needs, effectiveness of safety measures, and IFU	Azurion R2.1 was found to be safe and effective for the intended use, users and use environment. All executed validation protocols were passed.
Privacy and Security requirements met	Privacy and Security requirements have been implemented.
Reliability and performance requirements met	Performance and reliability testing performed; results demonstrated all executed verification tests were passed.
Azurion R2.1 is as safe and effective as its predicate device	Substantial equivalence conclusion based on non-clinical tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable in the context of clinical images/data for AI performance evaluation, as this submission did not involve a clinical study or AI performance evaluation on a test set of patient images. The "test set" here refers to the system itself undergoing verification and validation.
Data Provenance: Not applicable, as no patient data was used for a clinical performance study. The tests were non-clinical verification and validation of the device system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Usability validation was performed with "both interventional radiologists / cardiologists (physicians) and nurse/technicians." The exact number is not specified.
Qualifications of Experts: Interventional radiologists/cardiologists (physicians) and nurse/technicians. Specific years of experience are not mentioned. Their role was to validate usability and workflow in a simulated environment, not to establish ground truth for image data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This was not a study involving human reader interpretation of images requiring adjudication for ground truth. The "validation protocols" were executed by users, and the passing criteria would have been pre-defined operational outcomes rather than subjective interpretations needing adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. The document explicitly states: "The Azurion R2.1 did not require clinical study data since substantial equivalence to the currently marketed predicate device Azurion R1.2 was demonstrated..." This device is an X-ray system, not specifically an AI algorithm for image analysis that would typically undergo an MRMC study to show human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not explicitly stated as a separate "algorithm only" study. The device itself is an integrated system. The "ClarityIQ image processing algorithms" are mentioned as an optional feature, but their standalone performance is not detailed in this summary, nor is it the primary focus of this 510(k) submission which deems the entire device substantially equivalent.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable in the traditional sense of a clinical image-based study. For the verification and validation tests mentioned, the "ground truth" was compliance with established engineering specifications, risk mitigation strategies, international consensus standards, FDA guidance documents, and user needs as validated through simulated use.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document describes a medical device (an X-ray system), not an AI algorithm that would have a "training set" of patient data in the machine learning sense.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there was no AI training set as described for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Philips Medical Systems Nederland BV % Ms. Michelle Campbell Regulatory Affairs Specialist Veenpluis 4-6 Best. 5684PC NETHERLANDS

Re: K200917

Trade/Device Name: Azurion R2.1 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: April 2, 2020 Received: April 6, 2020

Dear Ms. Campbell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

May 1, 2020

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)
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K200917

Device Name Azurion R2.1

Indications for Use (Describe)

· Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

Additionally:

· The Azurion series can be used in a hybrid Operation Room
· The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

Patient Population

All human patients of all ages. Patient weight is limited to the specification of the patient table.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K200917

510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.

Date Prepared:	April 2nd 2020
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Michelle CampbellRegulatory Affairs OfficerPhone: +31 618345786E-mail: michelle.campbell@philips.com
Secondary ContactPerson:	Michael KoningsDirector of Regulatory IGT SystemsPhone: +31 619864032E-mail: michael.konings@philips.com
Device:	Trade Name:	Azurion R2.1
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21 CFR, Part 892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	Primary Code: OWBSubsequent Code: JAA
Predicate Device:	Trade Name:	Azurion R1.2
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K172822 (November 22, 2017)
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21 CFR, Part 892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	Primary Code: OWBSubsequent Code: JAA
Secondary PredicateDevice	Trade Name:	Azurion R2.0
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K181830 (August 02, 2018)
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Regulation:	21 CFR, Part 892.1650
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	Primary Code: OWBSubsequent Code: JAA
Device description:	The Azurion R2.1 is classified as an interventional fluoroscopic X-ray system.The primary performance characteristics of the Azurion R2.1 interventionalfluoroscopic X-ray system include:Real-time image visualization of patient anatomy during procedures Imaging techniques and tools to assist interventional procedures Post processing functions after interventional procedures Storage of reference/control images for patient records Compatibility to images of other modalities via DICOM Built in radiation safety controls This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures.The Azurion R2.1 is available in comparable models and configurations as the currently marketed and predicate device Azurion R1.2.Configurations are composed of detector type (monoplane and biplane), floor or ceiling mounted geometry, standard or OR table type and available image processing. The FlexArm option is available for the 7M20 configuration in Azurion R2.1 The monoplane (single C-arm) and biplane (dual arm) X-ray system configurations are differentiated by the following features: 12 inch Flat Detector (FD12) 15 inch Flat Detector (FD15) 20 inch Flat Detector (FD20) Additionally, identical to the predicate device, Azurion R2.1 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.
Indications for Use:	The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: The Azurion series can be used in a hybrid Operating Room.

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PHILIPS

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• The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

Patient Population:

All human patients of all ages. Patient weight is limited to the specification of the patient table.

Based on the information provided above, the Azurion R2.1 is considered substantially equivalent to the currently marketed and predicate device Azurion R1.2 in terms of Indications for Use.

Technological The Azurion R2.1 has similar technological characteristics compared to the characteristics: predicate device. The same hardware and software is used in the predicate and subject device, with exception of the following modifications implemented in the Azurion R2.1:

Multi Modality Touch Screen Module which is an incremental development of the current Touch Screen Module
Replacement of Windows 7 with Windows 10 OS ●
An update of the graphics boards in all PCs
. Introduction of the Pixium 2121S detector as an alternative 12" detector for monoplane systems
Inclusion of an optical imaging system within the FD20 detector outer frame. This option will not be enabled until the relevant application becomes available.
The next release of the Certeray generator (Certeray release 5)
The next release of the Poly-G geometry (Poly-G3) ● Extension of the Nicol V4 collimator for the Poly-G3 geometry (already introduced by release R2.0 for FlexArm options)
. Extension of the range with the introduction of additional Azurion 5 configurations
. Field feedback and minor updates from earlier releases

The differences between the Azurion R2.1 and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission. Azurion R2.1 is considered substantially equivalent to the currently marketed predicate Azurion R1.2 in terms of fundamental scientific technology.

Summary of Non-Non-clinical performance testing has been performed on the Azurion R2.1 and Clinical Performance demonstrates compliance with the following International and FDA-recognized Data: consensus standards and FDA guidance documents:

. IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
ISO 14971 Medical devices – Application of risk management to medical devices (Edition 2.0, corrected version 2007-10-01). FDA/CDRH recognition number 5-40.
. IEC 60601-2-28 - Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 3.0, 2017-06). FDA/CDRH recognition number 12-309.

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. IEC 60601-2-43 - Particular requirements for the safety of X-Rav equipment for interventional procedures (Edition 2.0, 2010-03).
. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
"Guidance for Industry and FDA Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices

Software verification testing of the functional and non-functional requirements as well as performance, reliability and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements have been implemented. Results demonstrated that all executed verification tests were passed.

Non-clinical validation testing has been performed to validate that Azurion R2.1 conforms to the intended use, claims, user and service needs, effectiveness of safety measures and instructions for use. The validation consisted of the following activities:

Usability validation was performed with both interventional radiologists / cardiologists (physicians) and nurse/technicians in a simulated use environment. Azurion R2.1 was found to be safe and effective for the intended use, users and use environment.

A simulated use design validation was undertaken with participants who fulfill the intended user profile. The participants executed validation protocols in the form of a clinical workflow to validate user needs, intended use, claims and effectiveness of the safety and instructions for use. Results demonstrated that all executed validation protocols were passed.

All these tests were used to support substantial equivalence of the subject device and demonstrate that Azurion R2.1:

complies with the above-mentioned international and FDA-recognized consensus standards and FDA guidance documents, and
. meets the acceptance criteria and is adequate for its intended use.

Therefore, Azurion R2.1 is substantially equivalent to the currently marketed Azurion R1.2 in terms of safety and effectiveness.

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Summary of Clinical Performance Data:

The Azurion R2.1 did not require clinical study data since substantial equivalence to the currently marketed predicate device Azurion R1.2 was demonstrated with the following attributes:

Indication for use;
. Technological characteristics;
. Non-clinical performance testing; and
. Safety and effectiveness.

These attributes demonstrated that the clinical performance of the modified device is substantially equivalent to the predicate device.

Substantial Equivalence Conclusion:

The Azurion R2.1 is substantially equivalent to the currently marketed predicate device Azurion R1.2 in terms of indications for use, technological characteristics and safety and effectiveness.

The modification of the Azurion R2.1 is within the controls and predetermined specifications. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that Azurion R2.1 complies with the user need requirements as well as the requirements specified in the FDA-recognized consensus standards and guidance documents.

Therefore Azurion R2.1 is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.